- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00725088
Study of Rehabilitation Therapy on Patients After Acute Myocardial Infarction
August 22, 2008 updated by: Ministry of Science and Technology of the People´s Republic of China
The purpose of this study is to determine whether exercise rehabilitation can reduce mortality, reinfarction or heart failure of patients after acute myocardial infarction.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100083
- Recruiting
- Peking University Third Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 74 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical diagnosis of ST-elevated myocardial infarction
- Heart function class I-II(killip classification)
- Agree to take cardiopulmonary exercise testing before discharge
- Signature of the informed consent document
Exclusion Criteria:
- History of myocardial infarction
- Acute myocardial infarction with severe complications(such as pulmonary edema, severe cardiac arrhythmia or cardiogenic shock)
- Atrial fibrillation
- Other severe diseases, such as HIV infection, malignant tumor or chronic diseases of liver, kidney or pulmonary
- Not be capable of exercise training
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
NO_INTERVENTION: 2
control group
|
|
|
EXPERIMENTAL: 1
exercise training group
|
Exercise training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cardiac mortality
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Non-fatal reinfarction, revascularization(PCI/CABG), ischemic stroke, unstable angina pectoris needs for hospitalization, severe heart failure needs for hospitalization
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Wei Gao, MD, Peking University Third Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (ANTICIPATED)
December 1, 2008
Study Completion (ANTICIPATED)
December 1, 2010
Study Registration Dates
First Submitted
July 28, 2008
First Submitted That Met QC Criteria
July 29, 2008
First Posted (ESTIMATE)
July 30, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
August 25, 2008
Last Update Submitted That Met QC Criteria
August 22, 2008
Last Verified
July 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006BAI01A02-10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.